Biagini Raymond E, MacKenzie Barbara A, Sammons Deborah L, Smith Jerome P, Krieg Edward F, Robertson Shirley A, Hamilton Robert G
Biomonitoring Research Team, Biomonitoring and Health Assessment Branch, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Cincinnati, Ohio 45226, USA.
Ann Allergy Asthma Immunol. 2006 Aug;97(2):196-202. doi: 10.1016/S1081-1206(10)60013-0.
In the absence of a US Food and Drug Administration (FDA)-cleared latex skin testing reagent, in vitro tests remain important for the diagnosis of latex allergy.
To evaluate the performance characteristics of IMMULITE 2000 3gAllergy (Immulite), a third-generation, FDA-cleared, continuous random-access immunoanalyzer, for the quantification of latex specific IgE.
Stored serum samples (N = 201) from patients classified as having positive or negative latex puncture skin test results were measured for latex specific IgE levels using Immulite, and these data were compared with historical results from 3 second-generation, FDA-cleared IgE antilatex assays (AlaSTAT [Ala], AutoCAP [CAP], and HY*TEC enzyme immunoassay [HT]).
The diagnostic performances of the CAP, Ala, and Immulite assays (> or = 0.35 kU/L cutoff value) were equivalent in sensitivity and specificity (P > .05). The HT assay (> or = 0.05 kU/L cutoff value) was more sensitive and less specific (P < .05). Immulite (> or = 0.10 kU/L cutoff value) had greater sensitivity than Ala and CAP and greater specificity than HT (P < .05 for both). Diagnostic efficiency was greater for Immulite than for CAP, Ala, and HT (P < .05).
The Immulite system is superior in diagnostic performance, especially at the 0.10 kU/L or greater cutoff level, for the diagnosis of latex allergy compared with older, second-generation assays. Immulite still misclassifies 15.5% of puncture skin test-positive individuals as negative for latex specific IgE. Compared with second-generation assays, Immulite represents a technological advance, with enhanced speed and less operator intervention.
在美国食品药品监督管理局（FDA）批准的乳胶皮肤试验试剂缺乏的情况下，体外试验对于乳胶过敏的诊断仍然很重要。
评估IMMULITE 2000 3gAllergy（免疫化学发光免疫分析仪）这一第三代、经FDA批准的连续随机接入免疫分析仪对乳胶特异性IgE进行定量检测的性能特征。
使用免疫化学发光免疫分析仪对储存的血清样本（N = 201）进行检测，这些样本来自被分类为乳胶点刺皮肤试验结果阳性或阴性的患者，以测定乳胶特异性IgE水平，并将这些数据与3种第二代经FDA批准的IgE抗乳胶检测方法（AlaSTAT [Ala]、自动变应原检测仪[CAP]和HY*TEC酶免疫分析[HT]）的历史结果进行比较。
CAP、Ala和免疫化学发光免疫分析检测方法（临界值≥0.35 kU/L）在敏感性和特异性方面相当（P > 0.05）。HT检测方法（临界值≥0.05 kU/L）更敏感但特异性较低（P < 0.05）。免疫化学发光免疫分析（临界值≥0.10 kU/L）比Ala和CAP具有更高的敏感性，比HT具有更高的特异性（两者P均< 0.05）。免疫化学发光免疫分析的诊断效率高于CAP、Ala和HT（P < 0.05）。
与旧的第二代检测方法相比，免疫化学发光免疫分析系统在乳胶过敏诊断的性能上更优，尤其是在临界值为0.10 kU/L或更高时。免疫化学发光免疫分析仍会将15.5%的点刺皮肤试验阳性个体误分类为乳胶特异性IgE阴性。与第二代检测方法相比，免疫化学发光免疫分析代表了一项技术进步，具有更快的速度和更少的操作人员干预。
